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 Blood, 15 November 2004, Vol. 104, No. 10, pp. 3052-3057.
Prepublished online as a Blood First Edition Paper on July 20, 2004; DOI 10.1182/blood-2004-02-0408.

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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized controlled trial

Antonio Palumbo, Sara Bringhen, Maria Teresa Petrucci, Pellegrino Musto, Fausto Rossini, Martina Nunzi, Vito Michele Lauta, Cesare Bergonzi, Anna Barbui, Tommaso Caravita, Antonio Capaldi, Patrizia Pregno, Tommasina Guglielmelli, Mariella Grasso, Vincenzo Callea, Alessandra Bertola, Federica Cavallo, Patrizia Falco, Cecilia Rus, Massimo Massaia, Franco Mandelli, Angelo Michele Carella, Enrico Pogliani, Anna Marina Liberati, Franco Dammacco, Giovannino Ciccone, and Mario Boccadoro

From the Divisione di Ematologia dell' Università di Torino and Struttura Complessa (SC) Ematologia Ospedaliera and Epidemiologia dei Tumori, Azienda Ospedaliera S. Giovanni Battista, and Divisione di Ematologia e Malattie Trombotiche, Ospedale Evangelico Valdese, Torino, Italy; Dipartimento di Biotecnologie ed Ematologia, Università La Sapienza and Cattedra e Divisione di Ematologia, Università Tor Vergata, Ospedale S. Eugenio, Roma, Italy; Unitá Operativa (UO) di Ematologia e Trapianto di Cellule Staminali, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Italy; Ematologia, H. S. Gerardo, Monza, Italy; Clinica medica I, Policlinico Monteluce, Perugia, Italy; Sezione di Medicina Interna e Oncologia clinica, Policlinico, Bari, Italy; Sezione di Ematologia, Azienda Istituti Ospedalieri, Cremona, Italy; Divisione di Ematologia, Ospedali Riuniti, Bergamo, Italy; Divisione di Oncologia ed Ematologia, IRCCS, Candiolo, Italy; Medicina Interna II, Azienda Ospedaliera San Luigi, Orbassano, Italy; Divisione di Ematologia, Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy; Divisione di Ematologia, Ospedali Riuniti, Reggio Calabria, Italy.

High-dose therapy is an effective standard treatment for multiple myeloma patients. Evidence that intermediate-dose therapy improves survival is limited. At diagnosis, about 70% of patients are older than 65. Intermediate-dose regimen is very well tolerated in older patients. In a multicenter study, 194 patients were randomized to receive at diagnosis either conventional chemotherapy (6 courses of oral melphalan and prednisone [MP]) or intermediate-dose therapy (2 courses of melphalan at 100 mg/m2 [MEL100]) with stem cell support. Response rate was higher after MEL100. Near-complete remission (nCR) was 6% after MP and 25% after MEL100 (P = .0002). At 3 years, MEL100 increased event-free survival (EFS) from 16% to 37% and overall survival (OS) from 62% to 77% (P < .001). Similar results were observed in patients aged 65 to 70: nCR was 8% after MP and 25% after MEL100 (P = .05); at 3 years, MEL100 improved EFS from 18% to 31% (P = .01) and OS from 58% to 73% (P = .01). Patients aged 65 to 70 had a median OS of 37.2 months (MP) versus 58 months (MEL100). Intermediate-dose melphalan improves response rate, EFS, and OS in myeloma patients, specifically in those aged 65 to 70. It constitutes a more effective first-line regimen than standard treatment for elderly patients.


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